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Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 755nm Alexandrite Laser with Handpiece 2 | Experimental | Focusing energy on skin |
|
| 755nm Alexandrite Laser with handpiece 3 | Experimental | Focusing energy on skin |
|
| 755nm Alexandrite laser with handpiece 1 | Experimental | Focusing energy on skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 755nm Alexandrite Laser with handpiece 2 | Device | Focusing energy on skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Biopsy Sampling | Histological examination of tissue samples will be compared between baseline and 3 months post treatment. | 3 months post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic evaluation as a measure of improvement. | 2D photographs to be taken at each visit and assessed at the end of the study by 2-3 blinded assessors for improvement. | up to 3 months post last treatment |
| Subject Biopsy Sampling |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | up to 3 months post last treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of New York | New York | New York | 10016 | United States |
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| 755nm Alexandrite Laser with handpiece 1 | Device | focusing energy at skin surface |
|
| 755nm Alexandrite Laser with handpiece 3 | Device | Focusing energy on skin |
|
Histological examination of tissue samples will be compared between baseline and 2 weeks post treatment.
| 2 weeks post treatment |
| Subject Biopsy Sampling | Histological examination of tissue samples will be compared between baseline and 1 month post treatment. | 1 month post treatment |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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